WHAT'S NEW SINCE THE LAST CONFERENCE

WELCOME MESSAGE

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Welcome AABB Delegates! You will find some useful resources for the annual meeting below.

 

*NEW* Clinical Trials Documents:


ST-022 – ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) – 1.0.0
This standard provides guidance on the use of a new category of Product Description Codes (PDCs) specifically developed for clinical trials products. These Clinical Trials PDCs are standardized global identifiers allocated by ICCBBA, which may be used by organizations licensed with ICCBBA, including clinical trials facilities, clinical trial sponsors, and cell and gene therapy manufacturers.

 

TB-018 – Labeling of Clinical Trial and Manufactured Cellular Therapy (CT) Final Products Using ISBT 128 – 1.0.0
This document helps users recognize various labeling scenarios that may apply to cellular therapy products.

*NEW* Split Label Examples for Apheresis & Cell Therapy Manufacturing:

 

ST-018 – ISBT 128 Standard Labeling for Apheresis Collection Products for Cellular Therapy Manufacturing – 1.0.0

This document provides instructions for the labeling of apheresis collection products for sponsor cellular therapy clinical trials and manufacturing. 

IG-045 – Implementation Guide: Applying ISBT 128 Labels to Collection Products for Further Manufacture – 1.0.0

The purpose of this document is to provide guidance to help users implementing standardized labeling of collection products for further manufacture in compliance with the ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing (ST-018).

*NEW* Standard for XML:

ST-020 – ISBT 128 Standard for XML – 1.0.0

The purpose of this standard is to provide specifications of XML elements for use in electronic messages in order to provide information regarding MPHO in a consistent and standardized format.

*NEW* General Technical Bulletins:

 

TB-015 – Bacterial Contamination Strategies for Platelets – US Guidance – 1.0.0

The purpose of this interim guidance is to assist US based blood facilities in the selection of the correct labels for labeling platelets in the US based on the FDA Guidance: Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion (September 2019)


TB-016 – Improving Quality of Care through Traceability – 1.0.0

ICCBBA has published a new technical bulletin, TB-016 Improving Quality of Care through Traceability, to describe how the use of ISBT 128 facilitates the inclusion of product identifiers into patient electronic health records.  Developments described within this document would have an immediate beneficial impact on traceability and would facilitate the electronic exchange of health information to improve quality of care for patients around the world.

 

*NEW* Joint Publication

JP-005 – Consensus Statement on Terminology Coding and Labeling of Cellular Therapy Products - v1.0.1

The Boards of AABB, APBMT, ASFA, ASTCT, Be The Match (NMDP), EBMT, EMBMT, FACT, ICCBBA, ISBT, ISCT, JACIE, LABMT, WBMT, and WMDA issued an updated consensus statement in support of the use of ISBT 128 in the coding of hematopoietic progenitor cell and other therapeutic cell products. The Boards of the above organizations encourage cell therapy facilities to use ISBT 128 product coding and labeling

 

 

*NEW* Cell Therapy Audit Tool


This tool is intended for auditors to help them assess compliance to ISBT 128 requirements for cellular therapy products. The audit tool can also be used by facilities wanting to perform a self-assessment or a gap analysis as part of their ISBT 128 implementation efforts.

WHAT'S NEW SINCE THE LAST MEETING

DOCUMENT LINKS

 

IG-002: United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 – 3.0.0
IG-003: United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 – 1.3.1 

IG-010: Implementation Guide: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution – 1.0.3

IG-013: Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples – 1.1.0
IG-014: Implementation Guide: Use of Data Matrix Symbols with ISBT 128 – 1.3.0

IG-015: Implementation Guide: Use of the Manufacturers Data File – 1.2.1
IG-021: Implementation Guide: Use of Product Code [Data Structure 003] for Blood – 1.1.0

IG-022: Implementation Guide: Product Coding [Data Structures 003 and 032] for Cellular Therapy – 1.2.0
IG-023: Implementation Guide: Use of Product Divisions [Data Structure 032] – 1.2.0

IG-024: Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – 1.2.0
IG-025: ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO – 1.0.0

IG-026: Implementation Guide: Use of Dimensions [Data Structure 029] – 1.3.0
IG-027: Implementation Guide: Use of Red Cell Antigens with Test History [Data Structure 030] – 1.2.0

IG-033: Implementation Guide: Use of the Donation Identification Number [Data Structure 001] – 1.2.0
IG-034: Implementation Guide: ISBT 128 Facility Identification Number  1.2.0

IG-041: Implementation Guide: ISBT 128 in Resource Limited Countries – 1.0.0
IG-043: Implementation Guide:  A Validation Tool for ISBT 128 Data Structures – 1.1.0

TB-003 – Apheresis Platelets - US Guidance – 1.0.0

TB-004 – ISBT 128 and Traceability – 1.6.0

TB-006 – What is an ISBT 128 Donation Identification Number?  1.4.0

IN-037 – ISBT 128 Implementation Plan – 1.0.0

STOP DATA ENTRY ERRORS NOW!

Visit AABB Virtual to view an on-demand video presentation by Paul Ashford, MSc. CEng. CSci on

Facilitating Electronic Information Transfer (AM21-57)

 
A presentation at the office

This video contains an overview of the features of the ISBT 128 Product Lookup Website Application and its functions.

PRODUCT LOOKUP WEB APP OVERVIEW

CTCLAG UPDATES

SUMMARY OF RECENT ACTIVITY

20 Jul 21 - The group discussed how to code and label HPC, APHERESIS that is CD34 enriched, but has a specific concentration of T cells from the negative fraction added back to the product. It was recognized that this product had enough clinical significance to differentiate it from other CD34 enrich products.  CTCLAG decided to create a new attribute to account for the T cells added back. This will result in new product description codes being added to the database.

 

The committee also discussed a request for a new class name of MSC, APHERESIS for a cell product containing mesenchymal stromal cells isolated from a MNC apheresis collection. After discussing the request and obtaining input from the ISCT MSC Committee, CTCLAG decided not to pursue the new class name at this time.

 

16 Mar 21 - Terminology was added to include the new class name of MSC, DECIDUA (Mesenchymal Stromal Cells derived from Decidua), and a new cryoprotectant attribute for Propylene Glycol. 

 

The issue of documentation of cellular therapy products in electronic health records is being discussed. The goal is to have traceability information of cellular therapy products in the electronic health records. Members will reach out to different software company groups and asses their progress on the topic of traceability information of cellular therapy products in electronic health records. ICCBBA, in coordination with the FDA, have submitted comments to USCDI (US Core Data for Interoperability) to have the MPHO Unique Identifier added to the USCDI required data for EHR traceability records.

8 Jan 21 - Clinical trials facilities and study sponsors can request Product Description Codes (PDCs) for their clinical trials products for a specific trial. ICCBBA will issue PDCs specifically for clinical trials products as requests are received and will maintain these codes in a separate Clinical Trials PDC Database.

15 Sep 20 - The proposal for a hybrid ISBT 128 sponsor label for apheresis collections as starting products for clinical trial products was approved and published in the ST-018 document. The hybrid label has the ISBT 128 Donation Identification Number (DIN) and Product Code information on the left half, and the right half of the label will contain standardized sponsor required information.

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ICCBBA would like to congratulate our 1000th Cellular Therapy Facility registered in Argentina, Hospital Privado Universitario De Cordoba! They will also be receiving an official certificate to commemorate this occasion. 

CONGRATULATIONS TO OUR 1000ᵗʰ CELL THERAPY FACILIY

VOLUNTEERING & CONTRIBUTIONS TO ISBT 128

Volunteer to contribute your time and expertise to the ongoing development of the ICCBBA ISBT 128 Standard. The adoption of the ISBT 128 Standard for labeling medical products of human origin has improved the standardization of product descriptions and traceability of MPHO across the world, but it is dependent on the technical expertise of volunteers. Volunteers provide the foundation for our knowledge base to help ICCBBA anticipate the needs of its users in the constantly evolving fields of blood, cells and tissues. More than 250 experts participate in the ICCBBA Technical Advisory Groups (TAG) and we are seeking additional experts across all areas of MPHO spectrum. Interested in learning more? Review the recent activity summary for the TAG(s) relevant to your experience.  Interested contributors may apply to become a member of a TAG by emailing your CV to technical.dir@isbt128.org. Please include your area of interest and expertise (i.e. cord blood, MSC, tissues) and a brief summary (100 words or less) describing your experience with ISBT 128. 

 
 
 
 

VENDORS & SOFTWARE DEVELOPERS LICENSED BY ICCBBA

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